LeadScope

Details

ABOUT THIS PROJECT

The ICH M7 guidance provides a specification for the use of in silico models for evaluating the genotoxicity of impurities in pharmaceuticals. The guidelines support the combined use of consensus models based on statistical-based (Q)SAR and expert rule-based computational toxicology combined with an expert opinion to support a regulatory submission. Leadscope and DC have established a partnership providing a market leading consulting service to execute the modelling and reporting requirements of such a regulatory submission. It is based on the regulatory-accepted Leadscope software developed in close collaboration with the US FDA.

ICH M7Consulting Service

Douglas Connect & Leadscope

Experience that makes a difference

The new ICH M7 guidance provides a specification for the use of in silico models for evaluating the genotoxicity of impurities in pharmaceuticals. The guidelines support the combined use of consensus models based on statistical-based (Q)SAR and expert rule-based computational toxicology combined with an expert opinion to support a regulatory submission.

Douglas Connect and Leadscope have established a partnership providing a market leading consulting service to execute the modelling and reporting requirements of such a regulatory submission.

The regulatory-accepted Leadscope software has been developed in close collaboration with the US FDA to satisfy the requirements for the ICH M7 guidance.

Douglas Connect scientists bring a depth of expertise in computational toxicology to execute all aspects of a client project. They have lead the creation of the OpenTox platform for validated (Q)SAR model building and regulatory reporting for REACH and the ToxBank infrastructure development.

Using their expertise and the Leadscope software, Douglas Connect can provide a complete outsourced solution to satisfy ICH M7 requirements.

Evaluation of client requirements
to support ICH M7

- Compliant (Q)SAR computational toxicology regulatory submissions
- Application of expert rule-based and statistical-based in silico models to generate results for client compounds
- Development of consensus models and rationale
- Provision of a chemical and biological interpretation of the results
- Preparation of an expert opinion for conflicting in silico results
- Provision of a detailed report to client containing results, analysis and expert opinion

EXPERTS behind the project

GLENN J. MYATT

Glenn Myatt, PhD is a Chief Scientific Officer, Co-Founder of US based Leadscope Inc.

He brings many years of experience developing chemoinformatics systems to support drug discovery. Dr. Myatt received his B.Sc. in computing from Oxford Brookes University, his M.Sc. in knowledge-based systems from Heriot-Watt University Edinburgh, UK, and his PhD in chemoinformatics from the University of Leeds, UK. His professional interests include the application of chemoinformatics to facilitate the rapid design of potent and safe drugs.

BARRY J. HARDY

Dr. Hardy was a National Research Fellow at the FDA Center for Biologics and Evaluation, a Hitchings-Elion Fellow at Oxford University and CEO of Virtual Environments International. Within OpenTox he has been leading the development of an open, interoperable, semantic web platform whose goal is to satisfy the needs of safety assessment through the creation of applications linking resources together for data, algorithms, models and ontologies. As described in the recent ALTEX papers he is motivating an international collaboration to develop an open, robust, well-maintained computer platform and ontology for this field, supporting the reliable use of data and concepts required for integrated analysis.